Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United States (SHIELD)

May 29, 2026 updated by: Novavax
To assess the impact of reactogenicity among health care workers and first responders receiving an updated 2024-25 Novavax COVID-19 vaccine as compared with those receiving an updated 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective interventional study of health care workers (HCW) and first responders (FR) receiving an updated 2024-25 COVID-19 vaccination at the University of Utah (UT). Participants can choose which COVID-19 vaccine type they would like to receive from the study team. For this study, health care workers and first responders are defined as anyone having direct face-to-face contact, defined as being within 3 feet, or about an arm's length, with patients as part of their full-time or part-time (greater than or equal to 20 hours per week) job responsibilities.

Approximately 660 health care workers and first responders from Salt Lake City, Utah and surrounding areas will be enrolled into the study. This study will only enroll participants who intend to get an updated 2024-25 COVID-19 vaccine during Fall/Winter 2024-25 SARS-CoV-2 virus circulation. Eligible participants will choose their desired vaccine type (protein subunit: Novavax, or mRNA: Pfizer). Study vaccinators will then administer the chosen vaccine. Following vaccination, study participants will receive a post vaccination questionnaire 48-hours after vaccine administration. Self-reported information on systemic and local reactogenicity symptoms, socio-demographics, occupational history, medical history, COVID-19 and flu vaccine history, and impact on daily activities and work will be collected through the post vaccination questionnaire.

Study Type

Interventional

Enrollment (Actual)

660

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18 years and older who have received at least one COVID-19 vaccination in the past 4 years
  • Health care workers or first responders who have direct face-to-face contact, defined as being within 3 feet, or about an arm's length, with patients as part of their full-time or part-time (greater than or equal to 20 hours per week) job responsibilities
  • Intends to receive a dose of the updated 2024-25 COVID-19 vaccine
  • Able to understand and provide informed consent
  • Comfortable reading and responding to text messages and emails sent in English or having an interpreter assist them
  • Able and willing to comply with all study requirements
  • Access to a smartphone, tablet, or computer to complete the consent, screener and study questionnaires

Exclusion Criteria:

  • Ongoing participation in other vaccine or investigational product trials within 90 days of study enrollment
  • History of self-reported severe allergic reaction to prior COVID-19 vaccine
  • Receipt of COVID-19 vaccine within 60 days of enrollment
  • Plans to receive additional vaccines within 7 days after the vaccination visit for study enrollment. (Co-administered vaccinations at time or day of COVID-19 vaccination are permissible)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2024-25 updated Novavax COVID-19
Participants will receive a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2024-2025 formula (JN.1 containing) in the deltoid muscle of the arm.
Biological: protein subunit: Novavax COVID-19 vaccine
Participants will receive a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2024-2025 formula (JN.1 containing) in the deltoid muscle of the arm.
Other Names:
  • 2024-25 COVID-19 vaccination
Active Comparator: Pfizer mRNA COVID-19
Participants will receive a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2024-2025 formula (KP.2 containing) in the deltoid muscle of the arm.
Biological: Pfizer mRNA COVID-19 vaccine
Participants will receive a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2024-2025 formula (KP.2 containing) in the deltoid muscle of the arm.
Other Names:
  • 2024-2025 formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with solicited systemic reactogenicity symptoms.
Time Frame: Day 0 to Day 2
Percentage of participants that experienced any solicited systemic reactogenicity symptoms after receiving a single dose of 2024-25 Novavax COVID-19 vaccine or 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine during the first two days post vaccination.
Day 0 to Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with solicited local reactogenicity symptoms.
Time Frame: Day 0 to Day 2
To determine the difference in the percentage of participants that experienced any solicited local reactogenicity symptoms after receiving a single dose of 2024-25 Novavax COVID-19 vaccine or 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine during first two days post vaccination.
Day 0 to Day 2
Number of Participants with solicited systemic reactogenicity symptoms
Time Frame: Day 0 to Day 2
Number of Participants with solicited systemic reactogenicity symptoms experienced by participants after receiving a single dose of 2024-25 Novavax COVID-19 vaccine or 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine during the first two days post vaccination.
Day 0 to Day 2
Percentage of participants that experienced multiple solicited systemic reactogenicity symptoms.
Time Frame: Day 0 to Day 2
Percentage of participants that experienced multiple solicited systemic reactogenicity symptoms after receiving a single dose of 2024-25 Novavax COVID-19 vaccine or 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine during the first two days post vaccination.
Day 0 to Day 2
Percentage of participants who experienced any local and systemic solicited reactogenicity symptoms.
Time Frame: Day 0 to Day 2
Percentage of participants who experienced any Local and systemic solicited reactogenicity symptoms that were reported as severity of 2 or higher after receiving a single dose of 2024-25 Novavax COVID-19 vaccine or 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine during the first two days post vaccination.
Day 0 to Day 2
Number of Participants Reporting Perceived Impact on Daily Activities (Work, Social, and Family Life)
Time Frame: Day 0 to Day 2
Number of participants experiencing any perceived impact on their work, social life, and family/home responsibilities within the first 2 days post-vaccination, comparing responses between Novavax and Pfizer-BioNTech mRNA vaccine recipients."
Day 0 to Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novavax

Collaborators

University of Utah

Investigators

  • Principal Investigator: Sarang K Yoon, MOH, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019nCoV-415

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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